US8251920B2 - Swing lance with integrated sensor - Google Patents

Abstract

An apparatus for lancing skin and collecting a liquid sample. The apparatus having a housing with an outer periphery and a rotatable arm having a lance to puncture the skin. A sample collection area is attached to the arm. The arm of the apparatus rotates from a first position to a second position. As the arm rotates, the lance extends beyond the housing allowing the lance to contact the user's skin and create a lance site. As the arm continues to move to the second position, the lance is brought out of contact with the user's skin and back within the housing while the collection area is brought into position. When the arm is located in the second position, the collection area is in substantially the same location as the lance site on the user's skin.

Description

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of allowed U.S. patent application Ser. No. 10/899,774, filed Jul. 27, 2004, that claims the benefit of the U.S. Provisional Application 60/490,019, filed on Jul. 28, 2003.

FIELD OF THE INVENTION

The present invention relates generally to body fluid monitoring devices, and more particularly to a lancing mechanism and body fluid collection system.

BACKGROUND OF THE INVENTION

It is often necessary to obtain a sample of a body fluid and perform an analysis of an analyte in that body fluid. Preferably, the obtaining of body fluid is as painless as possible, and the collection of the sample is as simple as possible. One example of a need to obtain a sample of a body fluid is in connection with a blood glucose monitoring system where a user must frequently use the system to monitor the user's blood glucose level.

Those who have irregular blood glucose concentration levels are medically required to regularly self-monitor their blood glucose concentration level. An irregular blood glucose level can be brought on by a variety of reasons including illness such as diabetes. The purpose of monitoring the blood glucose concentration level is to determine the blood glucose concentration level and then to take corrective action, based upon whether the level is too high or too low, to bring the level back within a normal range. The failure to take corrective action can have serious implications. When blood glucose levels drop too low—a condition known as hypoglycemia—a person can become nervous, shaky, and confused. That person's judgment may become impaired and that person may eventually pass out. A person can also become very ill if his blood glucose level becomes too high—a condition known as hyperglycemia. Both conditions, hypoglycemia and hyperglycemia, are both potentially life-threatening emergencies.

One method of monitoring a person's blood glucose level is with a portable, hand-held blood glucose testing device. The portable nature of these devices enables the users to conveniently test their blood glucose levels wherever they may be. To check the blood glucose level, a drop of blood is obtained from the fingertip using a separate lancing device. The lancing device contains a needle lance to puncture the skin. Once the requisite amount of blood is produced on the fingertip, the blood is harvested using the blood glucose testing device. The blood is drawn inside the testing device, which then determines the concentration of glucose in the blood. The results of the test are communicated to the user via a display on the testing device.

One problem related with the prior art devices containing a separate lance and sample collection mechanism is that the user must carry both devices with him. The need to carry multiple devices opens the possibility of forgetting or losing one of the devices. If the user forgets to bring both the lance and the testing device with him, he will not be able to test his blood; adverse consequences may result.

Another problem with a monitoring system comprising a lancing device to lance the skin and a separate collection unit to collect the blood is that there is a greater chance of contaminating the sample. The user must be careful that he does not contaminate the blood drop that forms on the lance site or contaminate the collection device used. If any contamination occurs, the test result may not accurately reflect the level of the glucose present in the tested blood.

A third problem with having a device for lancing and a separate device for collection is the size of the sample needed. Users prefer to make smaller cuts, also referred to as lance sites, on their skin to produce a blood sample. A smaller lance site is usually less painful to make than a larger lance site, and should heal more quickly than a larger lance site. Generally, a smaller lance site will produce a smaller blood sample. The smaller the sample, the more important proper collection of the sample becomes. And a smaller sample requires greater precision in placing the collection device relative to the lance site. If the collection device is not properly positioned relative to the lance site on the user's skin, the requisite amount of sample may not be collected. If the requisite amount of sample is not collected an underfill condition occurs. The results of analyzing an underfill will not accurately reflect the amount of glucose present in the sample, or in the user.

Another problem with current lancing devices is that accidental lancing may occur from the exposed lance. If the lance is exposed it may come into contact with the user's skin in a location that the user did not intend to serve as a lance site. This cut may be painful and limit the available locations for a lance site.

Accordingly, there exists the need of a device that combines lancing capability and collection capability into one instrument. The combination device should be suitable for lancing skin and aligning the collection device at the lance site, collecting a small sample of blood from a small lance site on the skin, and reducing risk of accidental lance sites being formed from an exposed lance.

SUMMARY OF THE INVENTION

An apparatus for lancing skin and collecting a liquid sample, having a housing with an outer periphery. The apparatus contains a rotatable arm having a lance to puncture the skin and a sample collection chamber attached to the arm. The arm of the apparatus rotates from a first position to a second position. As the arm rotates, the lance extends beyond the housing allowing the lance to contact the user's skin and create a lance site. As the arm continues to move to the second position, the lance is brought out of contact with the user's skin and back within the housing. When the arm is located in the second position, the collection area is in substantially the same location as the lance site on the user's skin.

BRIEF DESCRIPTION OF THE DRAWINGS

Other objects and advantages of the invention will become apparent upon reading the following detailed description in conjunction with the drawings in which:

FIG. 1 is a side view of an apparatus for sampling fluid and showing a housing and a rotatable arm.

FIG. 2 is a side view of the apparatus shown inFIG. 1 with the arm in a first position with the lance in the housing.

FIG. 3 is a side view of the apparatus shown inFIG. 2 as the arm rotates from the first position to a second position with the lance extended and lancing a site.

FIG. 4 is a side view of the apparatus ofFIG. 3 with the arm in the second position with the lance in the housing and a collection area positioned at the lance site.

FIG. 5A shows a top view of an alternate embodiment of the present invention in which a sample collection area can be removed from the apparatus.

FIG. 5B illustrates the embodiment ofFIG. 5A as a new sample collection area is being loaded into the apparatus.

FIG. 5C illustrates the embodiment ofFIG. 5A as the lance is extended beyond the outer periphery of the housing of the apparatus.

FIG. 5D illustrates the embodiment ofFIG. 5A with the sample collection area positioned in substantially the same position as the lance site that was made as shown inFIG. 5C.

DETAILED DESCRIPTION OF THE DRAWINGS

As discussed in the background section, the need to obtain a sample of blood and perform an analysis of that sample occurs frequently for persons with various medical conditions. Many people who suffer from conditions such as diabetes must regularly test the level of glucose contained in their blood. One way to perform this test would be with a device that combines the operation of lancing the skin and collecting the sample.

Referring now toFIG. 1, anapparatus10 for lancing skin and collecting a liquid sample is illustrated. Theapparatus10 has ahousing8 with anouter periphery23. Amovable arm11 is connected in thehousing8 to swing in a predefined path. Connected tomovable arm11 is alance12 and asample collection area13. As thearm11 swings, thelance12 is sequentially extended beyond theouter periphery23 and retracted intohousing8.

Referring now toFIG. 2, thearm11, which comprises thelance12, and thecollection area13, pivots aboutpoint22 as thearm11 swings from a first position to a second position. Thelance12 has asharp penetration end14 that is capable of lancing a user, thereby creating a lance site on the skin to obtain a liquid sample for analysis. In a preferred embodiment, thelance12 is a flat surface lying in the plane of rotation of thearm11. The flat surface is useful to stabilize thelance12 relatively to thearm11. Thecollection area13 is used to collect a liquid sample that forms at the lance site created by thelance12. The second position of thearm11 is predetermined to position thecollection area13 at the lance site created as thearm11 rotates to the second rotation.

In one embodiment of the current invention, thecollection area13 includes acapillary channel15 through which the sample moves as it is collected. As the sample moves up thecapillary channel15, displaced air exits from thecapillary channel15 via avent hole17. In the illustrated embodiment, thecollection area13 includes abiosensor16.

When an electrochemical biosensor is used, thebiosensor16 contains a reagent designed to react with the analyte in the sample and produce a change in current. The change in current is measured across traces18 and19. Additional detail concerning electrochemical biosensors is found in commonly owned U.S. Pat. No. 5,759,364, which is incorporated herein by reference in its entirety. The change in current is measured by a meter coupled toterminals20 and21 oftraces18 and19 coupled to electrodes (not shown) in the capillary.

Thecollection area13 may be provided with thebiosensor16 having a reaction area that includes a reagent for producing a reaction with an analyte within theliquid sample25. The reaction is indicative of the concentration of the analyte within that sample. In the case of a glucose tester, the reagent could be a mixture containing glucose oxidase and potassium ferricyanide. In one embodiment of the current invention, the biosensor is an electrochemical sensor. An optical sensor may also be used to analyze the liquid sample.

Another suitable biosensor is a colorimetric sensor; details of which is described in U.S. Pat. No. 5,723,284, which is incorporated herein by reference in its entirety.

To obtain a sample of blood, the user places theapparatus10 on hisskin24 at a site to lance. InFIG. 2, theapparatus10 is applied to theskin24 of the user. Therotatable arm11 is shown in a first position. Next, the user activates the device by for example, pressing the trigger mechanism on the apparatus10 (not shown). Pressing the trigger releases a torsion spring (not shown) that forces thearm11 to rotate from the first position to a second position. Thearm11 is, in the illustrated embodiment, a pendulum that swings through a predefined arc aboutpivot point22.

Referring now toFIG. 3, thearm11 is between the first position and the second position. Thepenetration end14 of thelance12 extends beyond theouter periphery23 of thehousing8 to cut theskin24 to a predetermined depth and create a lance site. The lance site on theskin24 allows a liquid sample25 (seeFIG. 4) to form near the lance site.

Referring now toFIG. 4, thearm11 rotated to the second position. The second position is a predefined stopping point for thependulum11 that positions thecollection area13 over the lance site to collect thesample25. At the second position, thepenetration end14 oflance12 is within thehousing8. Thecollection area13 is in substantially the same location of theskin24 at which thepenetration end14 of thelance12 created the lance site. When thesample collection area13 is over the lance site in theskin24, theliquid sample25 is able to move into thesample collection area13 viacapillary channel15, or be contacted by other sample structure used instead of the collection area.FIGS. 1-4 illustrate thecollection area13 spaced apart from thelance12. In some embodiments, thelance penetration end14 andcollection area13 are colocated.

A rotating lance, such as for example illustrated inFIGS. 1-4, can be combined with structure for storing a plurality of disposable sensors, in for example a cartridge. Referring now toFIG. 5A a top view of such anapparatus40 for lancing skin and positioning a disposable sensor to collect a liquid sample. Theapparatus40 has ahousing42 with anouter periphery44. Theapparatus40 comprises a rotatable arm46 (or disc46) having alance48 and anest50 for receiving a disposable sensor. Thehousing42 containscartridge52 comprising a stack of disposable sensors. Thedisc46 is adapted to rotate three hundred and sixty degrees within thehousing42. InFIG. 5A, thecartridge52 is sealed against thedisc46 and thelance48 is stored.

Referring now toFIG. 5B,arm46 is rotated ninety degrees clockwise from the position shown inFIG. 5A. Thenest50 is located under thecartridge52 so that a new sensor can be loaded. The sensor is pushed into thenest50 by spring pressure from within thecartridge52. Thelance48 is still located within thehousing42 and the lance drive, e.g., a spring, is cocked.

Referring now toFIG. 5C, thedisc46 is rotated ninety degrees clockwise from the position shown inFIG. 5B. Thelance48 is extended beyond theouter periphery44 of thehousing42 to puncture the skin. Asensor53 ejected fromcartridge52 is shown onnest50. Thecartridge52 comprising the stack of disposable sensors has not been moved and is again sealed against thedisc46.

Referring now toFIG. 5D, themovable disc46 is rotated ninety degrees clockwise from the position shown inFIG. 5C. Thelance48 is stored within thehousing42. Thesensor53 positioned onnest50 is positioned so that it is in substantially the same location as the lance site created by thelance48. In this position of thedisc46,sensor53 collects the liquid sample.

Thedisc46 is rotated ninety more degrees clockwise to eject the now usedsensor53 and store thenest50. Thedisc46 is then in the position shown inFIG. 5A.

Further details concerning disposable sensors and device for dispensing sensors is found in U.S. Pat. Nos. D456,514; 6,316,264; 5,854,074; 5,810,199; and 5,632,410, all of which are incorporated herein by reference in their entirety.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings herein described in detail. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

Claims (18)

1. An apparatus for lancing skin, collecting a liquid sample and determining an analyte concentration of a fluid sample, the apparatus comprising:

a housing sized to be handheld and having an outer periphery;

a lance for lancing skin, the lance being fully within the outer periphery of the housing in the first predefined position, the lance extending beyond the outer periphery of the housing in the second predefined position so as to create a lance site in skin of a user, the lance being fully within the outer periphery after creating the lance site in the skin of the user; and

a sample-collection area being positioned within an effective range of the lance site to collect the liquid sample, the sample-collection area being distinct and separate from the lance;

a fluid-testing area being in fluid communication with the sample-collection area, the fluid-testing area assisting in determining the analyte concentration of the fluid sample, the fluid-testing area and the sample-collection area being located in a general fixed relation to the lance,

wherein the lance and the sample-collection area simultaneously move in a single generally downwardly direction in forming the lance site and collecting the liquid sample after forming the lance site.

2. The apparatus ofclaim 1, wherein the sample-collection area overlaps at least a portion of the lance site when collecting the fluid sample.

3. The apparatus ofclaim 1, wherein the fluid-testing area includes a biosensor.

4. The apparatus ofclaim 3, wherein the biosensor is an electrochemical biosensor.

5. The apparatus ofclaim 3, wherein the biosensor is an optical biosensor.

6. The apparatus ofclaim 1, wherein the sample-collection area includes a capillary channel for collecting the fluid sample and moving the sample to the fluid-testing area, the fluid-testing area including a reagent for producing a reaction with an analyte in the sample indicative of the analyte concentration of the fluid sample.

7. The apparatus ofclaim 1, wherein the lance includes a generally flat blade end.

8. The apparatus ofclaim 1, wherein the fluid-testing area includes glucose oxidase.

9. The apparatus ofclaim 3, wherein the fluid-testing area includes glucose.

10. A method of lancing the skin, collecting a liquid sample and determining an analyte concentration of a fluid sample, the method comprising the acts of:

providing an apparatus having a housing with an outer periphery, the apparatus including a lance, a sample-collection area and a fluid-testing area, the lance being fully within the outer periphery of the housing in the first predefined position, the sample-collection area and fluid-testing area being distinct and separate from the lance, the fluid-testing area and sample-collection area being in fluid communication therewith, the fluid-testing area and the sample-collection area being located in a generally fixed position relative to the lance, the fluid-testing area assisting in determining the analyte concentration of the fluid sample;

positioning the apparatus at a site to be lanced;

moving the lance from the first predefined position to the second position extending beyond the outer periphery of the housing to create a lance site in skin of a user;

after creating the lance site, moving the lance from the lance site such that the lance is fully within the outer periphery of the housing;

positioning the sample-collection area within an effective range of the lance site;

collecting the liquid sample in the sample-collection area; and

determining the analyte concentration of the fluid sample,

wherein the lance and the sample-collection area simultaneously move in a single generally downwardly direction in forming the lance site and collecting the liquid sample after forming the lance site.

11. The method ofclaim 10, wherein the sample-collection area overlaps at least a portion of the lance site.

12. The method ofclaim 10, wherein the fluid-testing area includes a biosensor.

13. The method ofclaim 12, wherein the biosensor is an electrochemical biosensor.

14. The method ofclaim 12, wherein the biosensor is an optical biosensor.

15. The method ofclaim 10, wherein the sample-collection area includes a capillary channel for collecting the sample and moving the sample to the fluid-testing area, the fluid-testing area having a reagent for producing a reaction with an analyte in the sample indicative of the analyte concentration in the fluid sample.

16. The method ofclaim 10, wherein the lance includes a generally flat blade end.

17. The method ofclaim 10, wherein the fluid-testing area includes glucose oxidase.

18. The method ofclaim 12, wherein the fluid-testing area includes glucose oxidase.

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